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  1. Oct 2015
    1. New drug product exclusivity.

      There is a difference between a patent and exclusivity. A patent can be granted anywhere along the development cycle and can last up to 20 years. Exclusivity is the exclusive marketing rights granted upon approval and certain criteria must be met. Exclusivity can last anywhere from 180 days to 7 years. Frequently asked questions on patents and exclusivity. (2014, July 18). Retrieved October 12, 2015, from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm